Quality Engineer

5 days ago

ahmedabad, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full time
Designation - Sr. QC Officer (Male) Experience - 3 to 4 years in Api pharma
Salary – 3 to 4 Lakh
Qualification -BSc /MSc Chemistry
Location – Ankleshwar (Gujrat)
Responsibilities
1. Quality Control Activities:
- Perform all QC activities as per defined SOPs and document them promptly.
- Conduct analyses according to specifications, testing methods, and pharmacopoeia monographs.
2. Sample Analysis:
- Analyze raw materials, in-process materials, equipment cleaning verifications, vendor qualifications, and finished product samples accurately and on time.
- Prepare and maintain adequate standard solutions, reagents, and volumetric solutions.
3. Instrument Calibration:
- Conduct daily and scheduled calibrations of QC instruments.
- Report any out-of-calibration (OOC) conditions to Head QC and assist in investigations.
4. Documentation and Certification:
- Prepare certificates of analysis post-analysis.
- Perform raw and packing material sampling, analysis, and paste approved labels after document review.
5. Stability Chamber Maintenance:
- Maintain stability chambers for temperature, humidity, and recording.
- Manage stability sample charging and analysis as per schedule.
6. Water and External Analysis:
- Sample and analyze water.
- Send samples to approved external labs for analyses not supported on-site.
7. Inventory Management:
- Maintain stock of glassware, chemicals, and reagents for regular use.
- Arrange and store chemicals as per SOP.
8. Safety and Compliance:
- Follow lab safety rules and ensure the use of proper PPEs.
- Control waste generation and chemical spillage during analysis.
- Arrange lab waste collection and coordinate its destruction with ETP.
9. Teamwork and Training:
- Support Head QC in OOS investigations.
- Participate in on-the-job training and periodic training programs.
- Exhibit teamwork and assist colleagues and superiors.
10. Audit and Quality Policy:
- Provide document support for internal, customer, or regulatory audits.
- Follow company HR rules, quality policy, and basic GMP/GLP compliance.
11. Other Duties:
- Perform any additional tasks as assigned by the department head.

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